The Bio-Process Systems Alliance (BPSA), the national trade association of the single-use bio-processing industry, is pleased to announce the release of its 2014 technical guide, Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment.
Known as the “BPSA 2014 Particulates Guide,” the 12-chapter compendium was derived from a recognized need in the single-use technology (SUT) industry to address issues such as:
- Why particulates are an issue with SUT;
- Why particles in SUT may be a contamination risk to a formulated product and/or the patient treated with the product;
- How one can control particulates; and
- What steps to take when particulates are found and attributed to SUT.
The BPSA 2014 Particulates Guide was a dedicated 18-month project funded and executed by BPSA under the guidance of a volunteer member committee of subject-matter experts representing the following companies: Value Plastics, Inc., GSK Vaccines, Pall Life Sciences, EMD Millipore, Entegris, Dow Corning Corporation, Merck & Co. Inc., AdvantaPure/New Age Industries, Sanofi Pasteur, and The BioProcess Institute.
The document is intended for both SUT users and component and systems suppliers of single-use equipment. The guide also covers terms and definitions and is inclusive of a complete reference section.
Immediate electronic delivery of the guide is available for $295. Click here for the order form. You may also order a hard copy of the 25-page, full-color guide by contacting BPSA’s Jeanette McCool at mccoolj@socma.com.
Site License Agreements for fixed-fee internal corporate distribution of the Guide are available – please contact Kevin Ott for information at ottk@socma.com
Members of BPSA may continue to access the Guide free of charge at www.bpsalliance.org under the “Members” tab.
For more information e-mail BPSA Executive Director Kevin Ott at ottk@socma.com.
About BPSA
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees. For more information, please visit www.bpsalliance.org, or contact Executive Director Kevin Ott at ottk@socma.com.